Open access
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To cite: Hoelen T-­CA, de Bie RA,
Arts JJC, et al. Methodology and
application of three-­dimensional
technology for brace design
and production for treatment
in patients with adolescent
idiopathic scoliosis: a scoping
review protocol. BMJ Open
2023;13:e079673. doi:10.1136/
bmjopen-2023-079673
► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online
(http://dx.doi.org/10.1136/​
bmjopen-2023-079673).
Received 08 September 2023
Accepted 20 November 2023
© Author(s) (or their
employer(s)) 2023. Re-­use
permitted under CC BY-­NC. No
commercial re-­use. See rights
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BMJ.
1
Department of Orthopedic
Surgery and CAPHRI Research
School, Maastricht University
Medical Centre+, Maastricht,
The Netherlands
2
Department of Epidemiology
and CAPHRI Research School,
Maastricht University Medical
Centre+, Maastricht, The
Netherlands
Correspondence to
Thomáy-­Claire Ayala Hoelen;
​thomay.​hoelen@​mumc.​nl
Methodology and application of three-­
dimensional technology for brace
design and production for treatment in
patients with adolescent idiopathic
scoliosis: a scoping review protocol
Thomáy-­Claire Ayala Hoelen ‍ ‍,1 Rob A de Bie ‍ ‍,2 Jacobus JC Arts ‍ ‍,1
Paul C Willems ‍ ‍1
ABSTRACT
Introduction Conservative treatment for adolescent
idiopathic scoliosis (AIS) using bracing has proven to
be effective at reducing curve progression. However,
variation in brace design and lack of brace specificity
hamper clinical treatment outcomes as well as the
predictability and comparison hereof. To overcome
this, recent technological developments aim to
generate transparent and objective criteria for brace
manufacturing by applying computer-­aided design
software and additive manufacturing to produce braces
for scoliosis treatment. Yet, the extent of its applicability
and clinical implementation are to be determined. This
study will identify and map the available evidence for
the methodology and application of three-­dimensional
technology for the design and production of clinical braces
used for treatment in patients with AIS.
Methods and analysis This scoping review will be
conducted in accordance with the Preferred Reporting
Items for Systematic Reviews and Meta-­Analyses
extension for Scoping Reviews. This scoping review will
consider studies on methodology of three-­dimensional
technological methodology and applications that have
been or are currently being applied in brace treatment of
AIS. The following databases will be searched: MEDLINE,
Web of Science, Cochrane Database of Systematic
Reviews and Embase (OVID). Search limits will be applied;
for example, only articles written in the English language
published after 2000 will be included. The retrieved articles
will be screened independently by two researchers. A third
researcher will be consulted in case of disagreement.
Data from relevant articles will be independently extracted
by two researchers and presented in a tabular manner
accompanied by a descriptive narration.
Ethics and dissemination Considering the nature of the
study, no ethical approval needed to be requested. The
study result will be submitted to a peer-­reviewed journal.
BACKGROUND
Adolescent idiopathic scoliosis (AIS) refers to
a condition with unknown aetiology, in which
a three-­dimensional deformity of the spine is
Hoelen T-­CA, et al. BMJ Open 2023;13:e079673. doi:10.1136/bmjopen-2023-079673
Protocol
STRENGTHS AND LIMITATIONS OF THIS STUDY
⇒ The study provides an elaborate overview of the
state of evidence of using three-­dimensional tech-
nology in brace design and production for use in
adolescent idiopathic scoliosis treatment.
⇒ An extensive search in multiple databases will be
performed increasing the chances of exhaustive
inclusion.
⇒ The review will be limited to papers published after
2000 and only in the English language which could
potentially lead to selection bias.
present among patients aged 10–18.1–3 AIS is
defined as having a Cobb angle equal to or
exceeding 10° on a frontal standing radio-
graph.1 AIS is the most common type of spinal
deformity representing approximately 80%
of the scoliosis cases and is predominantly
present in young females. The prevalence in
the general population lies around 2%–4%.1 3
AIS can be treated conservatively as well
as surgically in case of severe curve progres-
sion (>45°–50°) and (potential) detrimental
effects on a patient’s health.4 Conservative AIS
treatment consists of physiotherapy, bracing
or a combination hereof. Brace treatment has
proven to be an effective non-­operative treat-
ment aimed at reducing curve progression.4–6
However, uniform and objective criteria for
brace manufacturing are currently lacking
due to the wide variety in bracing types, tech-
niques and brace management. A critical
barrier to the success of bracing treatment is
the compliance of brace wearing. Weinstein et
al reported an average bracing success rate of
72%, with success being defined as reaching
skeletal maturity without curve progression to
50° or more.6 Longer wearing time was found
to lead to higher treatment success rates, for
1
Open access
example, success rates of 90%–93% were found if the
brace was worn for a minimum of 12.9 hours per day. A
literature review conducted by El Hawary et al concluded
there were six additional risk factors for brace treatment
failure including poor in-­brace correction and vertebral
rotation. Additionally, aspects such as initial curve magni-
tude, initial coronal deformity angular ratio, pressure
applied by the pads on the spine and the experience of
the orthotist may also contribute to the long-­term success
of brace treatment regardless of brace compliance.7
Furthermore, factors such as labour-­ intensive manual
development of braces, lack of predictability of clinical
outcomes due to variation in brace design and patient
non-­specificity regarding the brace design may contribute
to suboptimal clinical outcomes. These factors could
potentially be addressed by improved brace manufac-
turing using three-­dimensional (3D) technology.5
Recent technological developments have focused on
the use of computer-­aided design software and additive
manufacturing, also known as 3D printing, of braces for
the treatment of scoliosis. The use of 3D printed orthotics
attempts to overcome the limitations of traditional
casting methods such as the lack of objective and trans-
parent criteria for the manufacturing of braces as well
as patient specificity regarding the brace design.8 New
techniques such as computer-­aided design and manufac-
turing (CAD-­CAM) or computer-­aided design and finite
element modelling (CAD-­FEM) allow for a more system-
atic approach when manufacturing a brace. It makes
use of radiographic images and normal photographs to
generate computer-­simulated models.8 The ultimate goal
when developing braces for the treatment of AIS with
the help of 3D technology is twofold; first, to provide a
more patient-­specific brace that has higher comfortability
and is more aesthetically pleasing, leading to increased
wearing compliance and second, to provide more objec-
tive and transparent manufacturing criteria that allow for
greater comparability and standardisation of outcomes
resulting from different types of braces. However, it is
still uncertain whether 3D manufactured braces provide
more predictable clinical outcomes for the patient.9 10
STUDY RATIONALE
A preliminary search of PROSPERO, MEDLINE, Web of
Science and the Cochrane Database of Systematic Reviews
was conducted to identify current or in-­progress scoping
reviews or systematic reviews on the topic. The search iden-
tified one review by Ali et al published in 2021 that briefly
considered the role of 3D applications for the conserva-
tive treatment of scoliosis.11 The review highlighted the
advancements in bracing treatment for patients with
scoliosis over time. Additionally, several reviews were
identified that focused on 3D printing techniques in
spinal surgery.12 13 Furthermore, a randomised controlled
trial was published recently, evaluating the clinical effec-
tiveness of a 3D printed brace when compared with
traditional bracing.10 The study reported similar clinical
2 Hoelen T-­CA, et al. BMJ Open 2023;13:e079673. doi:10.1136/bmjopen-2023-079673
BMJ Open: first published as 10.1136/bmjopen-2023-079673 on 9 December 2023. Downloaded from http://bmjopen.bmj.com/ on December 10, 2023 by guest. Protected by copyright.
effects for the two types of braces. However, this scoping
review will focus solely on the methodology and applica-
tion of 3D technology for brace design and production
and assess its effects on brace treatment in AIS. A scoping
review allows for identification and mapping of current
knowledge on technological methods and applications
in the design and production of braces used for clinical
AIS treatment as well as the identification of lacunas
within these processes. The current scoping review will
help guide further studies on the methodological options
and applications of 3D technology for brace treatment in
patients with AIS.
STUDY OBJECTIVES
The objectives of this scoping review are to identify and
map the available evidence for the methodology and
application of 3D technology for brace treatment of AIS.
Following this, the following subquestions will be
considered to help answer the main objective:
► What evidence is available on the methodology and
application of 3D technology for the design of braces
for the treatment of AIS?
► What evidence is available on the application of addi-
tive manufacturing to produce braces for the treat-
ment of AIS?
METHODS AND ANALYSIS
Protocol design and reporting
The methodology of this scoping review is based on the
scoping review manual from the Joanna Briggs Insti-
tute.14 Additionally, the framework introduced by Arksey
and O’Malley’s,15 and the methodological elaborations
suggested by Levac et al16 were consulted. The study will
be conducted in accordance with the Preferred Reporting
Items for Systematic Reviews and Meta-­Analyses exten-
sion for Scoping Reviews (PRISMA-­ScR).17 Additionally,
the scoping review protocol is registered in Open Science
Framework.18
Patient and public involvement
The Dutch Scoliosis Patient Society will be involved as a
reviewer in the final study.
Eligibility criteria
Population
In accordance with the objectives of this scoping review,
studies that consider patients of all genders with AIS
and an indication for brace treatment will be included.
Patients with scoliosis other than AIS will be excluded.
This review will consider studies that explore the meth-
odology and application of 3D technology in the design
and production of braces for the treatment of patients
with AIS. In the included studies, 3D technology will
refer to the technological methods applied such as CAD-­
CAM and CAD-­FEM software applications used to design
a brace for AIS treatment, whereas additive manufac-
turing refers to the techniques used in 3D printing the

brace. Orthotics used for applications other than AIS will
be excluded. Therefore, this scoping review will focus
primarily on the 3D technological methods and applica-
tions that are currently being applied to braces for the
treatment of AIS with the ultimate goal of improving
treatment.
Eligibility study designs
This scoping review will consider both experimental and
quasi-­experimental study designs including randomised
controlled trials, non-­ randomised controlled trials,
before-­ and-­after studies and interrupted time-­ series
studies. In addition, analytical observational studies
including prospective and retrospective cohort studies,
case–control studies and analytical cross-­ sectional
studies will be considered for inclusion. This review will
also consider descriptive observational study designs
including case series (n>10), individual case reports and
descriptive cross-­sectional studies and qualitative studies
for inclusion.
Search strategy
The search strategy aims to locate published studies. An
initial limited search of MEDLINE was undertaken to
identify articles on the topic. The text words contained in
the titles and abstracts of relevant articles, and the index
terms used to describe the articles were used to develop
a full search strategy (see online supplemental appendix
I). The search strategy, including all identified keywords
and index terms, will be adapted for each included data-
base and/or information source. The reference list of all
included sources of evidence will be screened for addi-
tional studies.
The following databases will be searched: MEDLINE,
Web of Science, Cochrane Database of Systematic Reviews,
Embase (OVID) and Google Scholar. Search limits will be
applied, for example, only articles written in the English
language published after the year 2000 will be included
considering the time period in which 3D technology and
additive manufacturing was first introduced. Articles that
are not available as full text will be excluded. Retrieved
articles will be screened on relevance by two researchers
independently. A third researcher will be consulted in
case of disagreement. Data from relevant articles will
be extracted by two researchers independently and
presented in tabular manner accompanied by a descrip-
tive narration.
Study/source of evidence selection
Following the search, all identified citations will be collated
and uploaded into EndNote V.X9.3.3 (Clarivate Analytics,
Pennsylvania, USA) and duplicates will be removed.
Subsequently, titles and abstracts will be screened by two
independent reviewers for assessment against the inclu-
sion criteria for the scoping review. Potentially relevant
sources will be retrieved in full and subsequently assessed
for inclusion by two reviewers independently. Potential
disagreements will be solved either via discussion or with
Hoelen T-­CA, et al. BMJ Open 2023;13:e079673. doi:10.1136/bmjopen-2023-079673
Open access
BMJ Open: first published as 10.1136/bmjopen-2023-079673 on 9 December 2023. Downloaded from http://bmjopen.bmj.com/ on December 10, 2023 by guest. Protected by copyright.
the help of a third reviewer. Reasons for exclusion of
sources of evidence at full text that do not meet the inclu-
sion criteria will be recorded and reported in the scoping
review. The results of the search and the study inclusion
process will be reported in full in the final scoping review
and presented in a PRISMA-­ScR flow diagram.19
Risk of bias
To get a general impression of the methodological quality
of the included studies, risk of bias assessment will be
performed using the Critical Appraisal Skills Programme
checklists.20
Data extraction and analysis
Data will be extracted by two independent reviewers using
a data extraction tool developed by the reviewers. Study
characteristics that will be extracted include but will not
be limited to the following: author, publication date,
country, study design, population characteristics if appli-
cable, type of 3D technological application, methodology
of 3D technology used, Risser stage, initial curve magni-
tude, curve type, in-­brace curve correction, duration of
brace wear, compliance, C-­DAR and patient satisfaction.
A draft extraction form is provided (see online supple-
mental appendix II). The draft data extraction tool will
be modified and revised as necessary during the process
of extracting data from each included evidence source.
Modifications will be detailed in the scoping review. Any
disagreements that arise between the two independent
reviewers will be resolved through discussion, or with a
third reviewer. If appropriate, authors of papers will be
contacted to request missing or additional data, where
required.
The data extracted from the included resources will
be used to map the methodology and application of 3D
technology in the workflow outline of brace construc-
tion and treatment. Emphasis will be placed on the type
of 3D technology used in the design, development and
construction phase of braces for treatment of patients
with AIS. Flow charts will be used to indicate the inclu-
sion and exclusion of resources. Data extracted from the
included studies will be presented in tabular format and
will be accompanied by a narrative summary describing
the relation between the results found and the objectives
of this scoping review.
Ethics and dissemination
Considering the nature of the study no ethical approval is
needed. This scoping review results will be published in a
peer-­reviewed journal.
Twitter Paul C Willems @Paul C Willems
Contributors T-­CAH concepted the study protocol, performed preliminary search,
drafted the protocol manuscript and is responsible for the final content of this
manuscript. RAdB performed the preliminary search and drafted the protocol
manuscript. JA and PW concepted this study protocol and critically reviewed
the protocol manuscript. All authors reviewed the final version of the protocol
manuscript.
Funding The authors have not declared a specific grant for this research from any
funding agency in the public, commercial or not-­for-­profit sectors.
3
 Open access
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in
the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not applicable.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
peer-­reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and
responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.
Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non-­commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
ORCID iDs
Thomáy-­Claire Ayala Hoelen http://orcid.org/0000-0001-9944-1831
Rob A de Bie http://orcid.org/0000-0001-5882-9303
Jacobus JC Arts http://orcid.org/0000-0002-2947-8564
Paul C Willems http://orcid.org/0000-0001-5996-7548
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